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BSI - BS EN ISO 10993-7

Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals

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Organization: BSI
Publication Date: 31 December 2008
Status: active
Page Count: 98
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

18/30355036 DC
August 16, 2018
Draft BS EN ISO 10993-7 Amendment 1 - Biological evaluation of medical devices. Part 7: Ethylene oxide sterilization residuals.
A description is not available for this item.
BS EN ISO 10993-7
December 31, 2008
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
A description is not available for this item.
BS EN ISO 10993-7
December 31, 2008
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
BS EN ISO 10993-7
April 15, 1996
Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
A description is not available for this item.

References

This document references:
90/385/EEC CORR - COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices
Published by EU on July 1, 2009
A description is not available for this item.
This document references:
93/42/EEC - Council Directive Concerning Medical Devices
Published by EU on June 14, 1993
Definitions, scope 1. This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both...
This document references:
ISO 11135 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by ISO on July 15, 2014
Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial...
This document is referenced by:
BS EN ISO 16061 - Instruments for use in association with non-active surgical implants — General requirements
Published by BSI on April 30, 2021
A description is not available for this item.
This document is referenced by:
BS EN ISO 22442-1 - Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
Published by BSI on December 31, 2020
A description is not available for this item.
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